Fycompa

Orange BookUNIISPLATC N03AX22

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCatalyst Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN03AX22

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6961627414
14 TABLET in 1 PACKAGE (69616-274-14)
ndc11
6961627430
30 TABLET in 1 BOTTLE (69616-274-30)
ndc11
6961627490
90 TABLET in 1 BOTTLE (69616-274-90)

Annotations

UNII (FDA Substance ID)

H821664NPK

PERAMPANEL

RxCUI 1356552

Orange Book

N202834

ABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "H821664NPK",
    "rxcui": "1356552",
    "inchikey": "PRMWGUBFXWROHD-UHFFFAOYSA-N",
    "display_name": "PERAMPANEL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "71cf3309-e182-473c-8b0b-280cabd0e122": {
      "match": "brand_token",
      "title": "FYCOMPA (PERAMPANEL) TABLET FYCOMPA (PERAMPANEL) SUSPENSION [EISAI INC.]",
      "spl_version": "60",
      "published_date": "2026-01-28"
    }
  },
  "productid": "69616-274_98f5e818-1e3f-43a8-9a56-9c44e639f431",
  "productndc": "69616-274",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202834",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Oct 22, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "Oct 22, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "003",
        "approval_date": "Oct 22, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "004",
        "approval_date": "Oct 22, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "005",
        "approval_date": "Oct 22, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "12MG",
        "product_no": "006",
        "approval_date": "Oct 22, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PERAMPANEL",
  "proprietary_name": "Fycompa",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202834",
  "marketing_category": "NDA",
  "nonproprietary_name": "perampanel",
  "start_marketing_date": "20240102",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N03AX22.

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